A Randomized Clinical Trial of Exercise vs. Usual Care Among Men Opting for Active Surveillance for Prostate Cancer


Condition: Localized Prostate Cancer, Active Surveillance for Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02435472

Sponsor: University of California, San Francisco

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  • ARM A and ARM B:
  • Histologically-documented localized (stage < T3) prostate adenocarcinoma
  • Patient has selected active surveillance as their management strategy for low- or low-intermediate risk prostate cancer as defined below
  • >= 10 core prostate biopsy completed prior to randomization with Gleason sum =< 6 with no pattern 4, or Gleason 3+4 in < 34% of all cores
  • Diagnostic or most recent prostate specific antigen (PSA) =< 15 ng/ml, or PSA density (PSAD) < 0.15
  • Low to moderate fitness level at baseline (to be assessed via interview with the exercise staff and through the CPET)
  • Clearance based on medical chart review and normal electrocardiogram (ECG) (administered by a trained health professional) to undergo a symptom-limited cardiopulmonary exercise test and aerobic training intervention
  • Able to achieve and complete an acceptable cardiopulmonary exercise test defined as follows: achieving peak or plateau in oxygen consumption concurrent with increased power output; a respiratory exchange ratio >= 1.1 or volitional exhaustion-rating of perceived exertion > 19
  • English-speaking
  • A priori, we will allow men with concurrent benign prostatic hyperplasia (prostate volume > 50 g) to have a PSA between 10-15 ng/ml; and include men with low volume Gleason 3+4 disease, because such men have similar outcomes on active surveillance to those with Gleason =< 3+3; also a priori, we will allow men with < than a 10 core biopsy at the discretion of the urologist if s/he classifies the patient as "low-risk" and a good candidate for active surveillance based on other favorable features (e.g., tumor molecular tests, prostate imaging, etc.) NON-CANCER CONTROL GROUP (EXPLORATORY ARM C):
  • Healthy males age 20-35 or >=60 yrs
  • No history of prostate cancer or other cancer
  • Medical clearance based on medical chart review and normal ECG (administered by a trained health professional) to undergo a symptom-limited cardiopulmonary exercise test and aerobic training intervention
  • English-speaking
  • Low to moderate fitness level at baseline (to be assessed via interview with the exercise staff and through the CPET; similar to Arms A and B); subjects will be frequency-matched to subjects in the prostate cancer exercise intervention group (Arm A) to have a similar distribution of body mass index and facilitate comparisons between these two groups NON-RANDOMIZED OBSERVATIONAL COMPONENT ELIGIBILITY:
  • Histologically-documented localized (stage < T3) prostate adenocarcinoma
  • Undergoing or initiating active surveillance
  • Medical clearance based on medical chart review and normal ECG (administered by a trained health professional) to undergo a symptom-limited cardiopulmonary exercise test and aerobic training intervention
  • English-speaking

Exclusion Criteria:

  • Any prior or concurrent treatment for prostate cancer
  • Use of finasteride or dutasteride within 3 weeks or 6 months, respectively, of study entry
  • Uncontrolled illness, physical disability, or other contraindication to aerobic exercise training including, but not limited to:
  • Acute myocardial Infarction (within 5 days of any planned study procedure)
  • Unstable angina
  • Uncontrolled arrhythmia causing symptoms or hemodynamic compromise
  • Recurrent syncope
  • Active endocarditis
  • Acute myocarditis or pericarditis
  • Symptomatic severe aortic stenosis
  • Uncontrolled heart failure
  • Acute (within 3 months) pulmonary embolus or pulmonary infarction
  • Thrombosis of lower extremities
  • Suspected dissecting aneurysm
  • Uncontrolled asthma
  • Pulmonary edema
  • Room air desaturation at rest =< 85%
  • Respiratory failure
  • Acute non-cardiopulmonary disorders that may affect exercise performance or be aggravated by exercise (ie infection, renal failure, thyrotoxicosis)
  • Mental impairment leading to inability to cooperate NON-RANDOMIZED OBSERVATIONAL AND INTERVENTION COMPONENTS (ARM C): • Should have no prior history of cancer, except for non-melanoma skin cancer

View trial on ClinicalTrials.gov